The phase 1b/2 trial evaluated a single, low-dose infusion of ciltacabtagene autoleucel (cilta-cel; JNJ-68284528) in heavily pretreated patients with relapsed or refractory multiple myeloma.
In an interview with CancerNetwork®, Deepu Madduri, MD, assistant professor of Medicine (Hematology and Medical Oncology), associate director of Cellular Therapy Service, and director of Clinical Operations with the Center of Excellence for Multiple Myeloma at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai, discussed the next steps for the CARTITUDE-1 trial (NCT03548207).
Preliminary results from the phase 1b/2 CARTITUDE-1 trial presented at the 62nd Annual ASH Meeting & Exposition suggested that a single low-dose infusion of ciltacabtagene autoleucel (cilta-cel; JNJ-68284528) resulted in early, deep, and durable responses in heavily pretreated patients with relapsed or refractory multiple myeloma.
Some of the plans for the next steps are [that] we are currently enrolling in CARTITUDE-2 [NCT04133636] and [CARTITUDE-4 (NCT04181827)]. And these are settings where we’re using it in earlier-line patients. So instead of waiting until you’ve failed 3 more prior therapies, this is [administered] sooner. And also, we’re exploring outpatient administration. A reason we’re exploring outpatient administration is because [of] cytokine release syndrome [CRS]; the [median] onset was about 7 days, with patients having CRS [on] day 4 or later [at] 89% and day six or later was 74%.
We think that understanding [this], maybe these patients can get their lymphodepleting chemotherapy [in the] outpatient [setting] and their CAR T cells outpatient, be monitored in an outpatient setting, then admit them if they need to be admitted for any complications or toxicities.